Home GUDID B040FRH26 FlexForm Annuloplasty Ring
Primary DI B040FRH26
Brand FlexForm Annuloplasty Ring
Company GENESEE BIOMEDICAL, INC.
Model FRH-26
Device description Annuloplasty Ring
Published 2017-02-01
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx false
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name KRH Ring, Annuloplasty
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KRH Ring, Annuloplasty Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B040FRH26 Package HIBCC 1 In Commercial Distribution B040FRH260 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Mitral/tricuspid annuloplasty ring A sterile circular band intended to be implanted in the heart for the reconstruction and/or remodelling of insufficient and/or stenotic mitral and tricuspid valves. It is typically mounted on a disposable holder assembly to enable it to maintain its shape and aid in its implantation with sutures. The device may be semi-rigid or flexible and may include metallic, polymeric, and/or textile materials; it is available in various sizes.
Regulatory Flags# DUNS number 939872651 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number true Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B040RPS181100 Thoracic Port with Obturator 18x110mm RPS-18110 2026-03-25 B040RPS18500 Thoracic Port with Obturator 18x50mm RPS-1850 2026-03-25 B040RPS18700 Thoracic Port with Obturator 18x70mm RPS-1870 2026-03-25 B040RPS18900 Thoracic Port with Obturator 18x90mm RPS-1890 2026-03-25 B040TF260 TransForm McCarthy Annuloplasty Ring TF-26 2024-12-23 B040TF280 TransForm McCarthy Annuloplasty Ring TF-28 2024-12-23 B040TF300 TransForm McCarthy Annuloplasty Ring TF-30 2024-12-23 B040TF320 TransForm McCarthy Annuloplasty Ring TF-32 2024-12-23 B040TF340 TransForm McCarthy Annuloplasty Ring TF-34 2024-12-23 B040TF380 TransForm McCarthy Annuloplasty Ring TF-38 2024-12-23 B040TF400 TransForm McCarthy Annuloplasty Ring TF-40 2024-12-23 B040TF240 TransForm McCarthy Annuloplasty Ring TF-24 2024-12-23 B040TF26 TransForm McCarthy Annuloplasty Ring TF-26 2024-12-23 B040TF28 TransForm McCarthy Annuloplasty Ring TF-28 2024-12-23 B040TF30 TransForm McCarthy Annuloplasty Ring TF-30 2024-12-23 B040TF32 TransForm McCarthy Annuloplasty Ring TF-32 2024-12-23 B040TF34 TransForm McCarthy Annuloplasty Ring TF-34 2024-12-23 B040TF360 TransForm McCarthy Annuloplasty Ring TF-36 2024-12-23 B040TF38 TransForm McCarthy Annuloplasty Ring TF-38 2024-12-23 B040TF40 TransForm McCarthy Annuloplasty Ring TF-40 2024-12-23
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